Plan to Widen Availability of Morning-After Pill Is Rejected

WASHINGTON — For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season.

The contraceptive pill, called Plan B One-Step, has been available without a prescription to women 17 and older, but those 16 and younger have needed a prescription — and they still will because of the decision by the health secretary, Kathleen Sebelius. If taken soon after unprotected sex, the pill halves the chances of a pregnancy.

Although Ms. Sebelius had the legal authority to overrule the F.D.A., no health secretary had ever publicly done so, an F.D.A. spokeswoman said. Nor had such a disagreement been the subject of such extraordinary dueling press statements. Dr. Margaret Hamburg, the F.D.A.’s commissioner, issued a lengthy statement saying it was safe to sell Plan B over the counter, while Ms. Sebelius countered that the drug’s manufacturer had failed to study whether girls as young as 11 years old could safely use Plan B.

Ms. Sebelius’s decision on an emotional issue that touches on parental involvement in birth control for teenage children is likely to have powerful political reverberations. Scientists and politicians have been at odds for years over whether to make Plan B available over the counter. The Bush administration at first rejected over-the-counter availability for women of any age, but ultimately allowed it for women 18 and older. After a federal court order, the Obama administration lowered the age to 17 in 2009.

With Ms. Sebelius’s decision on Wednesday, the Obama administration is taking a more socially conservative stance on Plan B, one closer to that of the Bush administration than to many of its own liberal supporters, even as President Obama has taken a tougher position on higher taxes on the wealthy to pay for a broad payroll tax cut — a stance popular with his political base.

For Dr. Hamburg, the studies and experts all agreed that young women would benefit from having easy access to the pill and did not need the intervention of a health care provider. The agency’s scientists, she wrote, “determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.”

In her own statement, Ms. Sebelius said, “After careful consideration of the F.D.A. summary review, I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” She was referring to Teva Pharmaceuticals, the pill’s maker. She noted that 10 percent of 11-year-old girls can bear children, so they needed to be studied as well.

Dr. Susan Wood, a former F.D.A. assistant commissioner who resigned in 2005 to protest the Bush administration’s handling of Plan B, said that there were many drugs available over the counter that had not been studied in pre-adolescents and that were far more dangerous to them.

“Acetaminophen can be fatal, but it’s available to everyone,” Dr. Wood noted. “So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?”

Norman Ornstein, a resident scholar at the American Enterprise Institute, said the Obama administration may be trying to assuage Catholic bishops and others angered in recent weeks by a decision requiring that health insurance programs created under the new health reform law offer contraceptives for free.

Photo

Kathleen Sebelius, the health secretary, top, and Dr. Margaret Hamburg, the head of the Food and Drug Administration.Credit
Tony Dejak/Associated Press

Teva Pharmaceuticals had applied to make Plan B easily accessible to everyone. The company issued a statement on Wednesday commending the F.D.A. for its recommendation to approve its application, adding that “we are disappointed that at this late date the Department of Health and Human Services has come to a different conclusion.”

The decision ensures that Plan B will continue to be far more important as a political issue than for public health. Though the pill has been found to be safe, experts said that wider availability would most likely have little to no measurable effect on pregnancy and abortion rates.

Even when young women are given free emergency contraceptives, they rarely take them after unprotected sex, studies have found. Women often miscalculate their menstrual cycle, or do not understand the risks of unprotected sex. As of now, half of all pregnancies are unplanned, more than 40 percent of children are born to unwed mothers, and 1.2 million abortions are performed every year involving one in every 50 women of reproductive age.

Plan B contains 1.5 milligrams of a synthetic version of the female hormone progesterone that is found in lower doses in daily contraceptive pills. It should be taken as soon as possible after sex since it gradually loses effectiveness, which is why advocates have pushed for years to make it available on store shelves. The drug’s principal effect is to prevent ovulation, but it may also make the lining of the uterus less hospitable to a fertilized egg. This latter effect — shared by all hormonal and intrauterine contraceptives — makes it anathema to anti-abortion activists. Plan B has no effect on established pregnancies, and it is not an abortion pill nor is it related to RU-486.

Women who have unprotected intercourse have about one chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about one in 40.

“Very few medications are this simple, convenient and safe,” said Dr. Kathleen Hill-Besinque, an assistant dean at the University of Southern California School of Pharmacy.

Jeanne Monahan of the Family Research Council, a conservative advocacy group, said that making Plan B available to young women without a prescription would mean fewer chances that doctors would be able to save them from sexual exploitation, abuse and related diseases. “Secretary Kathleen Sebelius was right to reject the F.D.A. recommendation to make this potent drug available over the counter to young girls,” she said.

Kirsten Moore, president of the Reproductive Health Technologies Project, said Ms. Sebelius had no credible scientific rationale for her decision. “We are outraged that this administration has let politics trump science,” she said.

The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have endorsed over-the-counter access to emergency contraception. Plan B was approved in 1999 as a prescription-only product, and it initially had few sales. In 2003, advocates filed an application for over-the-counter sales.

An expert advisory committee recommended approval, and scientists within the Food and Drug Administration unanimously supported that recommendation. Their rationale was simple: women can decide on their own when they need to take it, the drug is effective and its risks are minimal — particularly compared with pregnancy. But in a highly unusual move, top agency officials rejected the application because, some said later, they feared being fired if they approved it.

The agency delayed reconsideration for years despite promises by top Bush administration officials to do so. Then in 2006, the Bush administration allowed over-the-counter sales to women 18 and older but required a prescription for those 17 and younger. In 2009, the F.D.A. lowered the easy-access age limit by a year after a federal judge ruled that its decision had been driven by politics and not science.

A version of this article appears in print on December 8, 2011, on page A1 of the New York edition with the headline: F.D.A. Overruled On Availability Of After-Sex Pill. Order Reprints|Today's Paper|Subscribe